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Completed

NCT Number: NCT03524768

Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.

The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of Chagas disease, and to search for associations with clinical and laboratory variables.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

About this study

Chagas disease is an endemic anthropozoonosis in South America, caused by the protozoaTrypamosoma cruzi. Between 15 and 17 million people are estimated to be infected by the parasite in South America. During the chronic phase, 30 to 40% of patients develop the cardiac or intestinal forms of the disease. The myocardial involvement is divided in two subtypes, according to the presence or absence of systolic ventricular dysfunction. The first type is characterized by heart failure symptoms. The second is acknowledged by the development of various degrees of atrioventricular blockade and by tachyarrhythmias.

Microcirculation function is recognized as a fundamental aspect in the pathophysiology of cardiovascular diseases. The identification of endothelial dysfunction by techniques that assess the microvasculature is considered as both a progression and prognostic marker in various conditions, including hypertension, coronary heart disease, and heart failure.

The effects of T. cruzi infection in vascular function were evaluated in previous studies, performed in animals with acute infection. Previous studies in humans observed medium size vessels (brachial artery), in small groups of patients, most without cardiac dysfunction. There are no studies evaluating the microcirculation of patients with the cardiac form of Chagas disease.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients presenting with Chagas cardiomyopathy

Exclusion criteria

  • diabetes

Treatment and study plan

skin laser speckle contrast imaging and video-capillaroscopy

Diagnostic Test

Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment

Primary outcomes

  1. Endothelium-dependent skin microvascular function

    Time frame: 2 hours

    systemic microvascular vasodilation induced by endothelium-dependent agents

Secondary outcomes

  1. Endothelium-dependent skin capillary density

    Time frame: 1 hour

    capillary opening induced by post-occlusive reactive hyperemia

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 15, 2018
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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